Is this your brand? Sign in to claim ownership.
Sign in to claim this brandHEARTSINE TECHNOLOGIES LTD
US
Last updated May 30, 2026
Information
- Country
- US
- Address
- —
- Website
- stryker.com
- —
- —
- [email protected]
- Phone
- +1(215)860-8100
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 230479318
Catalogue (35)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HeartSine Samaritan PAD 450P | SAM450P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 350P | SAM 350P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 360P | SAM 360P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 450P | SAM450P | FDA UDI | Class III | Active |
| samaritan PAD | SAM360P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 360P | SAM 360P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 360P | SAM 360P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 350P | SAM 350P | FDA UDI | Class III | Active |
| Pad-Pak | Pad-Pak-01 | FDA UDI | Class III | Active |
| Pad-Pak | Pad-Pak-07 | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 450P | SAM 450P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 350P | SAM 350P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 360P | SAM360P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 360P | SAM360P | FDA UDI | Class III | Active |
| Pad-Pak | Pad-Pak-07 | FDA UDI | Class III | Active |
| Pediatric-Pak | Pad-Pak-02 | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 350P | SAM 350P | FDA UDI | Class III | Active |
| samaritan PAD | SAM 350P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 360P | SAM 360P | FDA UDI | Class III | Active |
| samaritan PAD | SAM 450P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 450P | SAM450P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 450P | SAM450P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 450P | SAM450P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 350P | SAM350P | FDA UDI | Class III | Active |
| HeartSine Samaritan PAD 350P | SAM 350P | FDA UDI | Class III | Active |
| Pad-Pak | Pad-Pak-01 | FDA UDI | Class III | Active |
| Pediatric-Pak | Pad-Pak-02 | FDA UDI | Class III | Active |
| Saver EVO | 1.4.0 | FDA UDI | Class III | Active |
| Reduced Energy Pediatric Electrode Pads For The Samaritan Aed And Pad, Models Sde 251, Spp 351 | K052465 | FDA 510(k) | Class III | Active |
| samaritan PAD 450P | K142709 | FDA 510(k) | Class III | Active |
| Heartsine Samaritan Pad | K041067 | FDA 510(k) | Class III | Active |
| Samaritan Aed, Model Sam-01 | K023854 | FDA 510(k) | Class III | Active |
| Heartsine Samaritan Pad 350p | K123881 | FDA 510(k) | Class III | Active |
| Samaritan Pad Pak Defibrillation Electrode, Model Spp-301 | K042088 | FDA 510(k) | Class III | Active |
| samaritan Public Access Automated External Defibrillators and Accessories | P160008 | FDA PMA | Class III | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 5, 2005 | Z-1046-05 | — | terminated | Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition. |
| Feb 14, 2005 | Z-0641-05 | — | terminated | The affected Automatic External Defibrillators (AED) annouce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Heartsine Technologies, Ltd BELFAST Northern Ireland · GB FEI 3004123209